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Biopharma Companies – But Not PhRMA – Argue That Mifepristone Ruling ‘Radically Alters’ NDA Process

 
• By Brenda Sandburg

BIO signs on while PhRMA and AAM stay on the sidelines as 169 companies, executives and investors file amicus brief supporting FDA’s request for stay of Judge Kacsmaryk’s decision to halt approval of the medication abortion drug. Members of Congress file opposing briefs.

Mifepristone
Biopharma companies aska appeals court to stay mifepristone ruling against FDA • Source: Shutterstock

The biopharma industry joined the legal battle over a Texas court ruling staying the US Food and Drug Administration’s approval of mifepristone. A group of 169 companies, senior executives, board members and investors asked the US Court of Appeals for the Fifth Circuit to stay, and ultimately reverse, the district court’s order, arguing that it would result in a “seismic shift” in the clinical development and drug approval process and that thousands of drugs would likely not have been approved under the court’s “groundless approach.”

The group filed an amicus brief on 11 April in support of motions by FDA and Danco Laboratories requesting...

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HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 
• By Sarah Karlin-Smith

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

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To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
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FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

More from Agency Leadership

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
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FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Delese Mimi Darko Appointed To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.